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CompletedNCT03337906Updated Apr 18, 2022

An Observational Study of Long-term Outcomes of HIV-1 Infection in Persons Who Become HIV-1 Infected After Enrollment in HIV-1 Vaccine Trials

An observational study in HIV Infections, sponsored by HIV Vaccine Trials Network. Completed at 21 sites in 6 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-18.

Sponsored by HIV Vaccine Trials Network · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
209
Ages
18 Years and older
Sex
All
01

Study summary

An observational study of long-term outcomes of HIV-1 infection in persons who become infected after enrollment in HIV-1 vaccine trials

Read the detailed description

A descriptive and observational study of long-term outcomes of HIV-1 infection in persons who become HIV-1 infected after enrollment in HIV-1 vaccine trials

02

Conditions studied

  • HIV Infections

Keywords

  • HIV
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Both vaccine and placebo recipients in HVTN trials in which HIV infection constitutes an endpoint (eg, test-of-concept, phase 2 and 3) who become HIV-1 infected after enrollment in the parent study and who meet the inclusion criteria may be offered enrollment in the study.

Inclusion criteria

  • Participants must meet the following criteria in order to be eligible for inclusion in the study:

    1. Confirmation of HIV-1 infection after enrollment in an HVTN vaccine trial in which HIV-1 infection constituted an endpoint, according to the diagnostic algorithm specified in the parent protocol.
    2. Ability and willingness to provide written informed consent to participate in the study.
    3. Ability and willingness to adhere to the on-study follow-up schedule.
    4. Ability and willingness to provide adequate information for locator purposes.
    5. Participants who are currently on ART or who previously received antiretrovirals as part of post-exposure prophylaxis, pre-exposure prophylaxis, or previous treatment regimen will be eligible for inclusion in this protocol. Their previous treatment history will be collected. If a participant has been on ART for more than 2 years, please consult with the protocol team leadership prior to enrollment.
    6. For participants initiating ART, agreement of participant and PHCP to initiate potent and durable ART regimens in accordance with local and international guidelines. Examples of potent and durable regimens are provided in Appendix H. Participants who initiate ART not consistent with regimens outlined in Appendix H may enroll with permission of the protocol chair or designee(s).

Exclusion criteria

Exclusion Criteria:

  • Persons who meet the following criteria will be excluded from the study:

    1. Any medical, psychiatric, alcohol/drug dependency or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or a participant's ability to give informed consent.
    2. Participants who meet these additional criteria will be excluded from the study:
  • Participants undergoing acute therapy for serious medical illnesses (in the opinion of the site investigator) within 14 days prior to initiation of ART.
  • Participants with chronic, acute, or recurrent infections that are serious (in the opinion of the site investigator).
  • Participants who must continue with chronic (maintenance) therapy (e.g., tuberculosis [TB], pneumocystis pneumonia [PCP]), must have completed at least 14 days of therapy and be clinically stable prior to initiation of ART.
  • Oral and vaginal candidiasis, mucocutaneous herpes simplex, and other minor illnesses, as defined by the site investigator, present no restriction to eligibility.
  • Participants undergoing radiation therapy, systemic chemotherapy, or receiving an immunomodulator within 45 days prior to initiation of ART. (A tapering course of corticosteroids as acute therapy for PCP or other conditions is an exception.)
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
209 participants (actual)
Patient registry
No

Groups and cohorts

  • Participants infected with HIV-1

    Persons who become HIV-1 infected after enrollment in HIV-1 vaccine trials

    Other: Observation

Interventions

  • OtherObservation
05

What researchers measure

Primary outcomes

  1. Measure plasma HIV-1 RNA levels and CD4+ T cell counts longitudinally

    Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.

    Time frame: 8 years

  2. Measure time to initiation of ART

    Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.

    Time frame: 8 years

  3. Measure time to HIV-1 related clinical events

    Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry. Responses from ELISpot assays will be reported as the number of spot-forming cells Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.

    Time frame: 8 years

  4. Proportion of individuals with plasma HIV-1 RNA level <50 copies/mL at 24 weeks after initiation of ART

    Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry. Responses from ELISpot assays will be reported as the number of spot-forming cells Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.

    Time frame: 8 years

Secondary outcomes

  1. Time from initiation of ART to treatment failure due to virologic, immunologic, and clinical reasons

    Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.

    Time frame: 8 years

  2. Occurrence of HIV/AIDS associated events, including death

    Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.

    Time frame: 8 years

  3. Proportion of subjects with HIV-1 RNA level <50 copies/mL post-initiation of ART; log change in plasma HIV-1 RNA levels and change in CD4+ T cell levels between baseline (at initiation of ART) and post-initiation of ART

    Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.

    Time frame: 24, 48, 96, and 144 weeks

  4. Adherence information collected at 24, 48, 96, and 144 weeks following initiation of ART

    Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.

    Time frame: 24, 48, 96, and 144 weeks

  5. Side effects collected at 24, 48, 96, and 144 weeks following initiation of ART

    Blood samples will be processed for PBMCs and then cryopreserved. These specimens will be stimulated with synthetic HIV-1 peptide pools. This process will allow ex vivo HIV-specific T-cell responses to be assessed by IFN-γ ELISpot and/or flow cytometry.

    Time frame: 24, 48, 96, and 144 weeks

06

Study locations

21 sites
  • Alabama Vaccine CRS
    Birmingham, Alabama 35294, United States
  • Bridge HIV CRS
    San Francisco, California 94143, United States
  • The Hope Clinic of the Emory Vaccine Center CRS
    Decatur, Georgia 30030, United States
  • UIC Project WISH CRS
    Chicago, Illinois 60612, United States
  • Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
    Boston, Massachusetts 02115-6110, United States
  • Fenway Health Clinical Research Site CRS
    Boston, Massachusetts 02215-4302, United States
  • NY Blood Ctr./Union Square CRS
    New York, New York 10003, United States
  • Columbia P&S CRS
    New York, New York 10032-3732, United States
  • NY Blood Ctr./Bronx CRS
    New York, New York 10455, United States
  • University of Rochester Vaccines to Prevent HIV Infection CRS
    New York, New York 14642, United States
  • Penn Prevention CRS
    Philadelphia, Pennsylvania 19104, United States
  • Vanderbilt Vaccine (VV) CRS
    Nashville, Tennessee 37232-2582, United States
  • Seattle Vaccine and Prevention CRS
    Seattle, Washington 98109-1024, United States
  • Unidad de Vacunas IDCP-COIN-DIGECITSS CRS
    Santo Domingo, Dominican Republic
  • Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS
    Port-au-Prince, HT-6110, Haiti
  • ACSA CRS
    Iquitos, Maynas 1, Peru
  • Maternal-Infant Studies Center (CEMI) CRS
    San Juan, 00935, Puerto Rico
  • Soweto HVTN CRS
    Johannesburg, Gauteng 1862, South Africa
  • eThekwini CRS
    Durban, Kwa Zulu Natal 4013, South Africa
  • Aurum Institute Klerksdorp CRS
    Klerksdorp, North West Province 2571, South Africa
  • Emavundleni CRS
    Cape Town, Western Cape 7750, South Africa
07

Registry details

Key details

Study ID
NCT03337906
Lead sponsor
HIV Vaccine Trials Network
Responsible party
Sponsor
First posted
Nov 9, 2017
Start date
Jul 11, 2008
Primary completion
Jul 11, 2015
Completion
Jul 1, 2016
Last update
Apr 18, 2022

Study contacts

Magdalena Sobieszcyk
study chair · Columbia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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